Actively Recruiting

Age: 18Years +
FEMALE
ID03774420

Post-Operative Cognitive Dysfunction After Breast Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI) in Women With Laryngeal Mask Airway

Led by University of Padova · Updated on 2026-04-21

200

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium in women undergoing breast surgery under general anesthesia. It aims to understand whether changes in neurocognitive test results before and after surgery relate to drug concentrations and common monitoring values during surgery. The study focuses on anesthesia delivered with targeted-controlled infusion of propofol and remifentanil and uses a laryngeal mask airway for airway management. Participants receive general anesthesia using propofol and remifentanil administered via targeted-controlled infusion, with the airway managed by a laryngeal mask. Researchers will monitor common intraoperative neuromonitoring values such as Bispectral Index, Entropy monitoring, and Surgical Plethysmographic Index, along with pupillometry measures including pupil diameter, latency, and maximum contraction velocity. The study observes neurocognitive functions and delirium occurrences linked to these anesthesia and monitoring parameters. Women enrolled will undergo several cognitive assessments before surgery and after awakening. These include the Montreal Cognitive Assessment, Trail Making Tests A and B, Digit Span Test, Confusion Assessment Method, Short Portable Mental Status Questionnaire, Mini-Mental State Evaluation, and the 4AT test. Evaluations occur one day before and within an hour to one day after surgery. The study tracks the incidence of cognitive dysfunction and delirium, aiming to correlate these outcomes with anesthesia drug levels and monitoring data over the study duration ending in 2027.

CONDITIONS

Brief Title

Post Operative Cognitive Dysfunction After Breast Surgery

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
  • Use of Laryngeal Mask airway
  • Female participants
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Neurological pathologies
  • Haemodynamical instability during surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo breast surgery under general anesthesia with Targeted Controlled Infusion and Laryngeal Mask Airway. Cognitive assessments and delirium evaluations occur shortly after surgery.

1 surgery day visit and assessments within 1 hour and 1 day after surgery

Post-operative Follow-up

Duration - 2 days

Participants complete additional cognitive function tests one day before and one day after surgery to assess post-operative cognitive dysfunction.

2 visits: 1 visit one day before surgery and 1 visit one day after surgery

Trial Site Locations

Total: 1 location

1

Treviso Regional Hospital

Treviso, TV, Italy, 31100

Actively Recruiting

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Research Team

F

Federico Linassi, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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